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Completed

NCT Number: NCT04502524

Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans

This phase I trial studies how well a new electronic (e)-health smoking cessation program (called Vet Flexiquit) works in promoting smoking cessation in low-income veterans who may or may not be ready to quit smoking. The study will compare the new website smoking cessation program to the current standard care website smoking cessation program offered by the Veterans Administration (VA). Both website interventions will be accompanied by a text messaging program that includes: (1) motivational messages, and (2) reminders to use the assigned program. Both of the website interventions can help smokers quit or cut back on how much they smoke, thus dramatically reducing their chances of developing tobacco-related health conditions.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bedford VA Research Corporation, Inc.

Bedford, Massachusetts, 01730, United States

About this study

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use the new website smoking cessation program, which provides values driven, mindfulness based coping skills and utilizes non-judgmental acceptance of uncomfortable internal states like cravings. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with handouts and available resources provided by the VA for continued support for smoking cessation.

ARM II: Participants use the VA standard of care website, which provides educational materials about cessation treatments, tools to cope with urges and relapse, how to stay motivated, and brief tips on coping with physical and mental health problems. Participants also receive text messages consisting of motivational messages and reminders to use the program. At the end of the program, participants receive an email with a handout of available resources provided by the VA for continued support for smoking cessation.

After study randomization, participants are followed up at 1 and 3 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be a US veteran
  • Participants must be low-income, as defined by falling below Veterans Health Administration (VHA) national income threshold for no-cost healthcare
  • Participants must be a current smoker, averaging at least 5 cigarettes/day for the last 30 days
  • Participants must have weekly internet access for the next 3 months
  • Participants must self-report current use of a personal email address to receive the link to their assigned web site
  • Participants must self-report being willing to complete all study activities
  • Participants must be willing to receive study-related text messages

Exclusion criteria

  • Currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
  • Have recent (past 30 days) substance use disorder, suicidal ideation, or psychiatric hospitalization
  • Previous participation in the treatment development stage of the new smoking cessation website program
  • Prior use of the SmokefreeVET web site
  • Member of the same household as another research participant
  • Woman who is pregnant or breastfeeding, or planning to become pregnant

Treatment and study plan

Smoking Cessation Intervention (New website)

Behavioral

Complete the new website smoking cessation program

Other names: Smoking and Tobacco Use Cessation Interventions

Smoking Cessation Intervention (Standard of care website)

Behavioral

Complete the standard of care website smoking cessation intervention

Other names: standard of care, standard therapy, best practice

Health Education

Behavioral

Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.

Health Promotion and Education

Other

Receive motivational and reminder text messages

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Satisfaction With Assigned Treatment

    Time frame: At 3 months post-randomization

    Satisfaction ratings regarding the usefulness of specific components of the website program, user comments and suggestions for improvement, presented descriptively. Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from "not at all satisfied" to "very satisfied". Will dichotomize values at a threshold of "somewhat satisfied" or higher. We tested for differences between arms using a Fisher's Exact test.

  2. Number of Server-recorded Logins to Assigned Website

    Time frame: At 3 months

    Will use negative binomial regression with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare treatment effects on the count outcome number of logins. There were no potential confounders to adjust for.

  3. Duration of Website Use (Days Since First Login)

    Time frame: At 3 months

    Will use negative binomial regression with adjustment for the stratification variable baseline readiness to quit (high versus low) to compare treatment groups on the secondary acceptability outcome of duration of site usage (number of days elapsed from first to last use). There were no confounders to adjust for.

Secondary outcomes

  1. Number of Quit Attempts

    Time frame: At 3 months

    Will use a negative binomial model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare the count outcome number of quit attempts between arms. There were no confounders to address for.

  2. Cotinine-confirmed, Self-reported Abstinence From Smoking

    Time frame: In the 7 days prior to the 3-month follow up

    Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered as continued smokers.

  3. Cotinine-confirmed, Self-reported Abstinence From Smoking

    Time frame: In the 30 days prior to the 3-month follow up

    Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. Missing responses were considered continued smokers.

  4. Self-reported Abstinence From All Nicotine and Tobacco Products (Except Nicotine Replacement Therapy)

    Time frame: In the 7 days prior to the 3-month follow up

    Will use a logistic regression model with adjustment for the stratification variable and baseline readiness to quit (high versus low) to compare smoking abstinence between arms. There were no confounders to adjust for. The missing responses were considered continued smokers.

  5. Change in Readiness to Quit

    Time frame: Baseline up to 3-month follow-up

    Will be assessed by the Contemplation Ladder on a scale from 0 (no thought about quitting) to 10 (taking action to quit). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for.

  6. Change in Acceptance of Smoking Triggers

    Time frame: Baseline up to 3-month follow-up

    Will be assessed by the Avoidance and Inflexibility Scale (AIS) on a scale ranging from 0 (never/not at all) to 4 (always/very much/extensively). Will calculate change score as follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variable and baseline readiness to quit (high versus low) to compare between study arms. There were no confounders to adjust for. This is the AIS Feelings score change.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Scalable e-Health Smoking Cessation Intervention for Socioeconomically Disadvantaged Veterans

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2020
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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